Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127569
Status:
TERMINATED
Last Update Posted:
2007-01-12
First Post:
2005-08-04
Brief Title:
Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Multicenter Phase II Trial Assessing the Efficacy of Rituximab in HIV Infected Patients With Multicentric Castleman Disease Dependent on Chemotherapy ANRS 117 Study CastlemaB
Status:
TERMINATED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is aimed to study the efficacy of 4 weekly cycles of rituximab in HIV-infected patients with multicentric Castleman disease giant lymph node hyperplasia dependent on chemotherapy Efficacy is assessed by the complete response rate at day 60 The patients are followed until day 365
Detailed Description:
HIV-related multicentric Castleman disease MCD is a lymphoproliferative disorder characterized by lymphadenopathy with angiofollicular hyperplasia and plasma cell infiltration associated with KSHVHHV-8 Patients typically have systemic manifestations such as fever associated with lymphadenopathy hepatosplenomegaly respiratory symptoms peripheral edema cytopenia hypergammaglobulinemia hypoalbuminemia and high levels of serum C reactive protein CRP Symptoms correlate with an important increase of KSHVHHV-8 DNA in peripheral blood mononuclear cells HIV-MCD is characterized by a rapidly progressive and often fatal course HIV-MCD is often refractory to treatment Vinca alkaloids produce frequent but short-lived responses and most patients remain dependant upon chemotherapy
Lymph nodes of patients with HIV-MCD specifically harbor the virus in B cells located in the mantle zone which stain positively for the CD20 surface antigen Rituximab a humanized monoclonal anti-CD20 antibody has been reported to be effective in some cases with conflicting data in other cases The optimal schedule of infusions remains unclear
Kaposis sarcoma is often associated with HIV-MCD and the development of aggressive non-Hodgkins lymphoma is not a rare outcome
Lymph nodes of patients with HIV-MCD specifically harbor the virus in B cells located in the mantle zone which stain positively for the CD20 surface antigen Rituximab a humanized monoclonal anti-CD20 antibody has been reported to be effective in some cases with conflicting data in other cases The optimal schedule of infusions remains unclear
Kaposis sarcoma is often associated with HIV-MCD and the development of aggressive non-Hodgkins lymphoma is not a rare outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None